Staple Cartridges for Forming Staples Having Differing Formed Staple Heights.

ABSTRACT

A staple cartridge for use with a stapling device that has an actuator that is selectively actuatable in an axial direction and an anvil portion that is selectively movable between open and closed positions is disclosed. Various embodiments of the present invention include a cartridge body that movably supports first and second staple drivers. The staple drivers each support a staple thereon and serve to drive the staples into forming contact with the anvil upon actuation by the actuator. The various embodiments of the present invention enable the final formed heights of the staples to be varied without the need to use different sizes of staples.

REFERENCE TO RELATED APPLICATIONS

This continuation application claims the benefit of U.S. patentapplication Ser. No. 11/216,562 entitled: “Staple Cartridge for FormingStaples Having different Formed Staple Height”, filed on Aug. 31, 2005.

FIELD OF THE INVENTION

The present invention relates in general to stapling instruments thatare capable of applying lines of staples and, more particularly, toimprovements relating to staple cartridges for use with surgicalstapling instruments that are capable of applying lines of stapleshaving differing formed staple heights to tissue while simultaneouslycutting the tissue.

BACKGROUND OF THE INVENTION

Surgical staplers have been used in the prior art to simultaneously makea longitudinal incision in tissue and apply lines of staples on opposingsides of the incision. Such instruments commonly include a pair ofcooperating jaw members that, if the instrument is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaw members receives a staple cartridgehaving at least two laterally spaced rows of staples. The other jawmember defines an anvil having staple-forming pockets aligned with therows of staples in the cartridge. The instrument includes a plurality ofreciprocating wedges that, when driven distally, pass through openingsin the staple cartridge and engage drivers supporting the staples toeffect the firing of the staples toward the anvil.

An example of a surgical stapler suitable for endoscopic applications isdescribed in U.S. Patent Application No. US 2004/0232196 A1, thedisclosure of which is herein incorporated by reference in its entirety.In use, a clinician is able to close the jaw members of the stapler upontissue to position the tissue prior to firing. Once the clinician hasdetermined that the jaw members are properly gripping tissue, theclinician can then fire the surgical stapler, thereby severing andstapling the tissue. The simultaneous severing and stapling avoidscomplications that may arise when performing such actions sequentiallywith different surgical tools that respectively only sever or staple.

Whenever a transaction of tissue is across an area of varied tissuecomposition, it would be advantageous for the staples that are closestto the cut line to have one formed height that is less than the formedheight of those staples that are farthest from the cut line. Inpractice, the rows of inside staples serve to provide a hemostaticbarrier, while the outside rows of staples with larger formed heightsprovide a cinching effect where the tissue transitions from the tightlycompressed hemostatic section to the non-compressed adjacent section. Inother applications, it may be useful for the staples in a single line ofstaples to have differing formed heights.

U.S. Pat. Nos. 4,941,623 and 5,027,834 to Pruitt disclose surgicalstapler and cartridge arrangements that employ staples that havedifferent prong lengths to ultimately achieve lines of staples that havediffering formed heights. Likewise, WO 2003/094747A1 discloses asurgical stapler and cartridge that has six rows of staples wherein theouter two rows of staples comprise staples that are larger than thestaples employed in the inner two rows and middle rows of staples. Thus,all of these approaches require the use of different sizes of staples inthe same cartridge.

Consequently, a significant need exists for an improved cartridge for astapling instrument that can form lines of staples that have differingformed heights without the need to employ different sizes of staples inthe same cartridge.

BRIEF SUMMARY OF THE INVENTION

In accordance with one embodiment of the present invention there is aprovided a staple cartridge for use with a stapling device that has anactuator that is selectively actuatable in an axial direction and ananvil portion that is selectively movable between open and closedpositions. In one embodiment, the staple cartridge comprises a cartridgebody that is supportable within the stapling device for selectiveconfronting relationship with the anvil portion thereof when in a closedposition. The cartridge body is configured to axially receive theactuator therein. The staple cartridge further comprises at least onefirst staple driver that is movably supported within the cartridge bodyfor contact by the actuator such that, as the actuator is axiallyadvanced through the cartridge body, the first staple drivers are drivenin a direction towards the anvil when the anvil is in the closedposition. Each of the first staple drivers has a first staple supportcradle therein for supporting a staple thereon. The first staple supportcradle is located a first staple forming distance from a correspondingportion of the closed anvil. At least one second staple driver ismovably supported within the cartridge body for contact by the actuatorsuch that as the actuator is axially advanced through the cartridgebody, the second staple drivers are driven in the direction towards theclosed anvil. Each second staple driver has a second staple supportcradle therein for supporting another staple thereon. The second staplesupport cradle is located a second staple forming distance from anotherportion of the closed anvil. The second staple forming distance differsfrom the first staple forming distance.

In accordance with another embodiment of the present invention, there isprovided a staple cartridge for use with a surgical instrument that hasan end effector that includes an anvil portion that is pivotallyattached thereto for travel between open and closed positions. Theinstrument further includes a firing bar that is selectively axiallyreciprocatable within the end effector. One embodiment of the staplecartridge comprises a cartridge body that is sized to be supportedwithin the end effector. The cartridge body has a longitudinallyextending slot therein for reciprocatingly receiving the firing bartherein. The cartridge further comprises a first plurality of insidestaple drivers that are axially aligned in a first row of inside stapledrivers on a first side of the longitudinally extending slot in thebody. A second plurality of inside staple drivers are also axiallyaligned in a second row of inside staple drivers on a second side of thelongitudinally extending slot. The inside staple drivers are movablysupported within the cartridge body for selective movement towards theanvil when the anvil is in a closed position. Each inside staple driverhas a first staple support cradle for supporting a staple thereon. Thefirst staple support cradles are each located a first staple formingdistance from a corresponding portion of the anvil when the anvil is ina closed position. The cartridge further comprises a first plurality ofoutside staple drivers that are axially aligned in a first row ofoutside staple drivers. The first row of outside staple drivers islocated on the first side of the longitudinally extending slot and isadjacent to the first row of the inside staple drivers. The cartridgefurther includes a second plurality of outside staple drivers axiallyaligned in a second row of outside staple drivers. The second row ofoutside staple drivers is located on the second side of said elongatedslot and is adjacent to the second row of inside staple drivers. Each ofthe outside staple drivers is movably supported within the cartridgebody for selective driving movement towards the anvil when the anvil isin the closed position. Each of the outside staple drivers have a secondstaple support cradle for supporting another one of the staples thereon.Each second staple support cradle is located a second staple formingdistance from another corresponding portion of the anvil when the anvilis in the closed position. The second staple forming distance differsfrom the first staple forming distance. A wedge sled is supported withinthe cartridge body for driving contact by the firing bar and actuatingcontact with the first and second pluralities of inside and outsidestaple drivers such that, as the firing bar moves within the elongatedslot in a first axial direction, the wedge sled drives each of theinside and outside drivers toward the anvil to bring the staplessupported thereon into forming contact with the anvil when the anvil isin the closed position.

In accordance with another embodiment of the present invention there isprovided a staple cartridge for use with a surgical instrument that hasan end effector that includes an anvil portion that is pivotallyattached thereto for travel between open and closed positions and whichfurther includes a firing bar that is selectively axially reciprocatabletherein. One embodiment of the staple cartridge comprises a cartridgebody that is sized to be supported within the end effector. Thecartridge body has a longitudinally extending slot therein forreciprocatingly receiving the firing bar therein. A plurality of firstinside staple drivers is axially aligned in a first row of first insidestaple drivers on a first side of the longitudinally extending slotwithin the cartridge body. Each of the first inside staple drivers ismovably supported within the cartridge body for selective movementtowards the anvil when the anvil is in a closed position. Each of thefirst inside staple drivers supports at least one staple thereon. Thisembodiment further includes a plurality of first outside staple driversthat are axially aligned in a first row of first outside staple driversthat is adjacent to the first row of the first inside staple drivers.Each of the first outside staple drivers is movably supported within thecartridge body for selective driving movement toward the anvil when theanvil is in the closed position. Each of the first outside stapledrivers supports another one of the staples thereon. The cartridgefurther comprises a wedge sled that is supported within the cartridgebody for contact by the firing bar. The wedge sled comprises a firstinside sled cam that has a first sled cam height. The first inside sledcam is oriented for sequential sliding actuating contact with the firstinside staple drivers in the first row of first inside staple driverswhen the firing bar is axially advanced through the elongated slot in afirst axial direction such that the first inside staple drivers aredriven toward the anvil a first distance equal to the first sled camheight. The wedge sled further comprises a first outside sled cam thathas a second sled cam height that differs from the first sled camheight. The first outside sled cam is oriented for sequential actuatingcontact with the first outside staple drivers in the first row of thefirst outside staple drivers when the firing bar is axially advancedthrough the elongated slot in the first axial direction such that thefirst outside staple drivers are driven towards the anvil a seconddistance equal to the second sled cam height.

One feature of various embodiments of the present invention is toprovide a staple cartridge for a stapling device that employs rows orother pluralities of identically sized staples while facilitating theability of forming the staples with differing formed (final) heights. Insome embodiments, the final heights may be varied across adjacent rowsof staples. In other embodiments, the formed heights of the staples maybe varied from staple to staple in a single row of staples. Accordingly,various embodiments of the invention provide solutions to theshortcomings of other staple cartridges and stapling devices that mustemploy different sizes of staples to achieve staples that have varyingformed heights. Those of ordinary skill in the art will readilyappreciate, however, that these and other details, features andadvantages will become further apparent as the following detaileddescription proceeds.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain the principles of the present invention.

FIG. 1 depicts a partially cut away side elevation view of a surgicalstapling and severing instrument in an open position.

FIG. 2 depicts a cross-sectional side elevation detail view along theline 2-2 of FIG. 1 of an end effector of the surgical stapling andsevering instrument.

FIG. 3 depicts an enlarged side elevation view of the firing bar of thesurgical stapling and severing instrument of FIG. 2.

FIG. 4 depicts an enlarged front view of the firing bar of the surgicalstapling and severing instrument of FIG. 2.

FIG. 5 depicts a cross-sectional side elevation detail view of analternative end effector for the surgical stapling and severinginstrument of FIG. 1, incorporating a firing bar that lacks a middle pinfor preventing pinching of the end effector.

FIG. 6 depicts a side elevational view of a handle portion of a proximalend of the surgical stapling and severing instrument of FIG. 1 with aleft side removed to expose interior parts in an unclamped, unfired(“start”) position.

FIG. 7 depicts a perspective, exploded view of the handle portion of theproximal end of the surgical stapling and severing instrument of FIG. 1.

FIG. 8 depicts a side elevational view of the handle portion of theproximal end of the surgical stapling and severing instrument of FIG. 1with the left side removed to expose interior parts in the closed(“clamped”) position.

FIG. 9 depicts a side elevational view of the handle portion of proximalend of surgical stapling and severing instrument of FIG. 1 with the leftside removed to expose interior parts in the stapled and severed(“fired”) position.

FIG. 10 depicts a plan view of a staple cartridge installed in an endeffector of an embodiment of the present invention.

FIG. 11 is an enlarged plan view of a portion of a staple cartridgeembodiment of the present invention.

FIG. 12 is a side view of a staple that may be employed with variousembodiments of the present invention.

FIG. 13 is a front elevational view of one inside double driver of oneembodiment of the present invention supporting two staples thereon.

FIG. 14 is a top view of the inside double driver and staples of FIG.13.

FIG. 14A is an elevational view of the inside double driver of FIG. 13within a portion of a staple cartridge mounted in the end effector andalso illustrating a corresponding portion of the anvil when in a closedposition.

FIG. 15 is a right side elevational view of the inside double driver andstaples of FIGS. 13 and 14.

FIG. 15A is another side elevational view of the inside double driver ofFIG. 15 wherein corresponding portions of the cartridge tray and anvilare illustrated in broken lines to depict the relationshipstherebetween.

FIG. 16 is a front elevational view of one outside single driver of oneembodiment of the present invention supporting a staple thereon.

FIG. 16A is another front view of the outside single driver of FIG. 16with portions of the cartridge tray and anvil shown to illustrate therelationships therebetween.

FIG. 17 is a top view of the outside single driver and staple of FIG.16.

FIG. 18 is an isometric exploded view of the implement portion of thesurgical stapling and severing instrument of FIG. 1.

FIG. 19 is a section view taken along line 19-19 of FIG. 10 showing thecross-sectional relationship between the firing bar, elongate channel,wedge sled, staple drivers, staples and staple cartridge.

FIG. 20 is a perspective view of one wedge sled embodiment of thepresent invention.

FIG. 21 is a side elevational view of an inside sled cam of the wedgesled depicted in FIG. 20.

FIG. 22 is a side elevational view of an outside sled cam of the wedgesled depicted in FIG. 20.

FIG. 23 is an isometric view of the end effector at the distal end ofthe surgical stapling and severing instrument of FIG. 1 with the anvilin the up or open position with the cartridge largely removed exposing asingle staple driver and a double staple driver as exemplary and thewedge sled in its start position against a middle pin of the firing bar.

FIG. 24 is an isometric view of the end effector at the distal end ofthe surgical stapling and severing instrument of FIG. 1 with the anvilin the up or open position exposing the staple cartridge and cuttingedge of the firing bar.

FIG. 25 is an isometric view of the distal end of the surgical staplingand severing instrument of FIG. 1 with the anvil in the up or openposition with the staple cartridge completely removed and a portion ofan elongate channel removed to expose a lowermost pin of the firing bar.

FIG. 26 is a side elevation view in section showing a mechanicalrelationship between the anvil, elongate channel, and staple cartridgein the closed position of the surgical stapling and severing instrumentof FIG. 1, the section generally taken along lines 26-26 of FIG. 24 toexpose wedge sled, staple drivers and staples but also depicting thefiring bar along the longitudinal centerline.

FIG. 27 is a cross-sectional view of a portion of one embodiment of astaple cartridge of the present invention wherein an outside cam of awedge is adjacent to an outside single driver.

FIG. 28 is a cross-sectional view of a portion of one embodiment of astaple cartridge of the present invention wherein an outside cam of awedge sled is engaging three outside single drivers.

FIG. 29 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument of one embodiment of the present invention.

FIG. 30 depicts a staple formed by one inside driver embodiment of thepresent invention.

FIG. 31 depicts another staple formed by one outside driver embodimentof the present invention.

FIG. 32 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument of another embodiment of the present invention.

FIG. 33 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument of another embodiment of the present invention.

FIG. 34 is a diagrammatic representation of lines of staples installedon each side of a cut line using a surgical stapling and severinginstrument of another embodiment of the present invention.

FIG. 35 is a side elevation section view of the surgical stapling andsevering instrument of FIG. 1 taken along the longitudinal centerline ofthe end effector in a partially closed but unclamped position grippingtissue.

FIG. 36 depicts a partially cut away side elevational view of thesurgical stapling and severing instrument of FIG. 1 in the closed orclamped position.

FIG. 37 depicts a side elevation view of the surgical stapling andsevering instrument of FIG. 1 in the closed or clamped position withtissue properly compressed.

FIG. 38 depicts a view in centerline section of the distal end of thesurgical stapling and severing instrument of FIG. 1 in a partially firedposition.

FIG. 39 depicts a partially cut away side elevation view of the surgicalstapling and severing instrument of FIG. 1 in a partially firedposition.

FIG. 40 depicts a view in centerline section of the distal end of thesurgical stapling and severing instrument of FIG. 1 in a fully firedposition.

FIG. 41 is a partially cut-away side elevational view of the surgicalstapling and severing instrument of FIG. 1 in a full fired position.

DETAILED DESCRIPTION OF THE INVENTION

Turning to the Drawings, wherein like numerals denote like componentsthroughout the several views, FIGS. 1 and 2 depict one embodiment of asurgical stapling and severing instrument 10 that is capable ofpracticing the unique benefits of the present invention. As the presentDetailed Description proceeds, the reader will appreciate, however, thatthe unique and novel aspects of the present invention may beadvantageously employed in connection with a variety of other staplersand stapler instruments without departing from the spirit and scope ofthe present invention. Accordingly, the scope of protection afforded tothe various embodiments of the present invention should not be limitedto use only with the specific type of surgical stapling and severinginstruments described herein.

As can be seen in FIGS. 1 and 2, the surgical stapling and severinginstrument 10 incorporates an end effector 12 having an actuator orE-beam firing mechanism (“firing bar”) 14 that advantageously controlsthe spacing of the end effector 12. In particular, an elongate channel16 and a pivotally translatable anvil 18 are maintained at a spacingthat assures effective stapling and severing. The problems are avoidedassociated with varying amounts of tissue being captured in the endeffector 12.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handle of an instrument.Thus, the end effector 12 is distal with respect to the more proximalhandle portion 20. It will be further appreciated that for convenienceand clarity, spatial terms such as “vertical” and “horizontal” are usedherein with respect to the drawings. However, surgical instruments areused in many orientations and positions, and these terms are notintended to be limiting and absolute.

The surgical and stapling and severing instrument 10 includes a handleportion 20 that is connected to an implement portion 22, the latterfurther comprising a shaft 23 distally terminating in the end effector12. The handle portion 20 includes a pistol grip 24 toward which aclosure trigger 26 is pivotally drawn by the clinician to causeclamping, or closing, of the anvil 18 toward the elongate channel 16 ofthe end effector 12. A firing trigger 28 is farther outboard of theclosure trigger 26 and is pivotally drawn by the clinician to cause thestapling and severing of clamped tissue in the end effector 12.

In practice, closure trigger 26 is actuated first. Once the clinician issatisfied with the positioning of the end effector 12, the clinician maydraw back the closure trigger 26 to its fully closed, locked positionproximate to the pistol grip 24. Then, the firing trigger 28 isactuated. The firing trigger 28 springedly returns when the clinicianremoves pressure. A release button 30 when depressed on the proximal endof the handle portion 20 releases any locked closure trigger 26.

A closure sleeve 32 encloses a frame 34, which in turn encloses a firingdrive member 36 that is positioned by the firing trigger 28. The frame34 connects the handle portion 20 to the end effector 12. With theclosure sleeve 32 withdrawn proximally by the closure trigger 26 asdepicted, the anvil 18 springedly opens, pivoting away from the elongatechannel 16 and translating proximally with the closure sleeve 32. Theelongate channel 16 receives a staple cartridge 37.

With particular reference to FIGS. 2-4, the firing bar 14 includes threevertically spaced pins that control the spacing of the end effector 12during firing. In particular, an upper pin 38 is staged to enter ananvil pocket 40 near the pivot between the anvil 18 and elongate channel16. When fired with the anvil 18 closed, the upper pin 38 advancesdistally within a longitudinal anvil slot 42 extending distally throughanvil 18. Any minor upward deflection in the anvil 18 is overcome by adownward force imparted by the upper pin 38. Firing bar 14 also includesa lowermost pin, or firing bar cap, 44 that upwardly engages a channelslot 45 in the elongate channel 16, thereby cooperating with the upperpin 38 to draw the anvil 18 and the elongate channel 16 slightly closertogether in the event of excess tissue clamped therebetween.

The firing bar 14 advantageously includes a middle pin 46 that passesthrough a firing drive slot 47 formed in a lower surface of thecartridge 300 and an upward surface of the elongate channel 16, therebydriving the staples therein as described below. The middle pin 46, bysliding against the elongate channel 16, advantageously resists anytendency for the end effector 12 to be pinched shut at its distal end.To illustrate an advantage of the middle pin 46, FIG. 5 depicts analternative end effector 12′ that lacks a middle pin on a firing bar14′. In this depiction, the end effector 12′ is allowed to pinch shut atits distal end, which tends to impair desired staple formation.

Returning to FIGS. 2-4, a distally presented cutting edge 48 between theupper and middle pins 38, 46 on the firing bar 14 traverses through aproximally presented, vertical slot 49 in the cartridge 37 to severclamped tissue. The affirmative positioning of the firing bar 14 withregard to the elongate channel 16 and anvil 18 assure that an effectivecut is performed.

The affirmative vertical spacing provided by the E-Beam firing bar 14 issuitable for the limited size available for endoscopic devices.Moreover, the E-Beam firing bar 14 enables fabrication of an anvil 15with a camber imparting a vertical deflection at its distal end, similarto the position depicted in FIG. 5. This cambered anvil 15advantageously assists in achieving the desired gap in the end effector12 even with an anvil 15 having a reduced thickness, which may be moresuited to the size limitations of an endoscopic device.

With reference to FIGS. 6-9, the handle portion 20 is comprised of firstand second base sections 50 and 52, which are molded from a polymericmaterial such as a glass-filled polycarbonate. The first base section 50is provided with a plurality of cylindrically-shaped pins 54. The secondbase section 52 includes a plurality of extending members 56, eachhaving a hexagonal-shaped opening 58. The cylindrically-shaped pins 54are received within the hexagonal-shaped openings 58 and arefrictionally held therein for maintaining the first and second basesections 50 and 52 in assembly.

A rotating knob 60 has a bore 62 extending completely through it forengaging and rotating the implement portion 22 about its longitudinalaxis. The rotating knob 60 includes an inwardly protruding boss 64extending along at least a portion of the bore 62. The protruding boss64 is received within a longitudinal slot 66 formed at a proximalportion of the closure sleeve 32 such that rotation of the rotating knob60 effects rotation of the closure sleeve 32. It will be appreciatedthat the boss 64 further extends through frame 34 and into contact witha portion of the firing drive member 36 to effect their rotation aswell. Thus, the end effector 12 (not shown in FIGS. 6-9) rotates withthe rotating knob 60.

A proximal end 68 of the frame 34 passes proximally through the rotatingknob 60 and is provided with a circumferential notch 70 that is engagedby opposing channel securement members 72 extending respectively fromthe base sections 50 and 52. Only the channel securement member 72 ofthe second base section 52 is shown. The channel securement members 72,extending from the base sections 50, 52 serve to secure the frame 34 tothe handle portion 20 such that the frame 34 does not movelongitudinally relative to the handle portion 20.

The closure trigger 26 has a handle section 74, a gear segment section76, and an intermediate section 78. A bore 80 extends through theintermediate section 78. A cylindrical support member 82 extending fromthe second base section 52 passes through the bore 80 for pivotablymounting the closure trigger 26 on the handle portion 20. A secondcylindrical support member 83 extending from the second base section 52passes through a bore 81 of firing trigger 28 for pivotally mounting onthe handle portion 20. A hexagonal opening 84 is provided in thecylindrical support member 83 for receiving a securement pin (not shown)extending from the first base section 50.

A closure yoke 86 is housed within the handle portion 20 forreciprocating movement therein and serves to transfer motion from theclosure trigger 26 to the closure sleeve 32. Support members 88extending from the second base section 52 and securement member 72,which extends through a recess 89 in the yoke 86, support the yoke 86within the handle portion 20.

A proximal end 90 of the closure sleeve 32 is provided with a flange 92that is snap-fitted into a receiving recess 94 formed in a distal end 96of the yoke 86. A proximal end 98 of the yoke 86 has a gear rack 100that is engaged by the gear segment section 76 of the closure trigger26. When the closure trigger 26 is moved toward the pistol grip 24 ofthe handle portion 20, the yoke 86 and, hence, the closure sleeve 32move distally, compressing a spring 102 that biases the yoke 86proximally. Distal movement of the closure sleeve 32 effects pivotaltranslation movement of the anvil 18 distally and toward the elongatechannel 16 of the end effector 12 and proximal movement effects closing,as discussed below.

The closure trigger 26 is forward biased to an open position by a frontsurface 130 interacting with an engaging surface 128 of the firingtrigger 28. Clamp first hook 104 that pivots top to rear in the handleportion 20 about a pin 106 restrains movement of the firing trigger 28toward the pistol grip 24 until the closure trigger 26 is clamped to itsclosed position. Hook 104 restrains firing trigger 28 motion by engaginga lockout pin 107 in firing trigger 28. The hook 104 is also in contactwith the closure trigger 26. In particular, a forward projection 108 ofthe hook 104 engages a member 110 on the intermediate section 78 of theclosure trigger 26, the member 100 being outward of the bore 80 towardthe handle section 74. Hook 104 is biased toward contact with member 110of the closure trigger 26 and engagement with lockout pin 107 in firingtrigger 28 by a release spring 112. As the closure trigger 26 isdepressed, the hook 104 is moved top to rear, compressing the releasespring 112 that is captured between a rearward projection 114 on thehook 104 and a forward projection 116 on the release button 30.

As the yoke 86 moves distally in response to proximal movement of theclosure trigger 26, an upper latch arm 118 of the release button 30moves along an upper surface 120 on the yoke 86 until dropping into anupwardly presented recess 122 in a proximal, lower portion of the yoke86. The release spring 112 urges the release button 30 outward, whichpivots the upper latch arm 118 downwardly into engagement with theupwardly presented recess 122, thereby locking the closure trigger 26 ina tissue clamping position, such as depicted in FIG. 8.

The latch arm 118 can be moved out of the recess 122 to release theanvil 18 by pushing the release button 30 inward. Specifically, theupper latch arm 118 pivots upward about pin 123 of the second basesection 52. The yoke 86 is then permitted to move proximally in responseto return movement of the closure trigger 26.

A firing trigger return spring 124 is located within the handle portion20 with one end attached to pin 106 of the second base section 52 andthe other end attached to a pin 126 on the firing trigger 28. The firingreturn spring 124 applies a return force to the pin 126 for biasing thefiring trigger 28 in a direction away from the pistol grip 24 of thehandle portion 20. The closure trigger 26 is also biased away frompistol grip 24 by engaging surface 128 of firing trigger 28 biasingfront surface 130 of closure trigger 26.

As the closure trigger 26 is moved toward the pistol grip 24, its frontsurface 130 engages with the engaging surface 128 on the firing trigger28 causing the firing trigger 28 to move to its “firing” position. Whenin its firing position, the firing trigger 28 is located at an angle ofapproximately 45° to the pistol grip 24. After staple firing, the spring124 causes the firing trigger 28 to return to its initial position.During the return movement of the firing trigger 28, its engagingsurface 128 pushes against the front surface 130 of the closure trigger26 causing the closure trigger 26 to return to its initial position. Astop member 132 extends from the second base section 52 to prevent theclosure trigger 26 from rotating beyond its initial position.

The surgical stapling and severing instrument 10 additionally includes areciprocating section 134, a multiplier 136 and a drive member 138. Thereciprocating section 134 comprises a wedge sled in the implementportion 22 (not shown in FIGS. 6-9) and a metal drive rod 140.

The drive member 138 includes first and second gear racks 141 and 142. Afirst notch 144 is provided on the drive member 138 intermediate thefirst and second gear racks 141, 142. During return movement of thefiring trigger 28, a tooth 146 on the firing trigger 28 engages with thefirst notch 144 for returning the drive member 138 to its initialposition after staple firing. A second notch 148 is located at aproximal end of the metal drive rod 140 for locking the metal drive rod140 to the upper latch arm 118 of the release button 30 in its unfiredposition.

The multiplier 136 comprises first and second integral pinion gears 150and 152. The first integral pinion gear 150 is engaged with a first gearrack 154 provided on the metal drive rod 140. The second integral piniongear 152 is engaged with the first gear rack 141 on the drive member138. The first integral pinion gear 150 has a first diameter and thesecond integral pinion gear 152 has a second diameter which is smallerthan the first diameter.

FIGS. 6, 8 and 9 depict respectively the handle portion 20 in the startposition (open and unfired), a clamped position (closed and unfired) anda fired position. The firing trigger 28 is provided with a gear segmentsection 156. The gear segment section 156 engages with the second gearrack 142 on the drive member 138 such that motion of the firing trigger28 causes the drive member 138 to move back and forth between a firstdrive position, shown in FIG. 8, and a second drive position, shown inFIG. 9. In order to prevent staple firing before tissue clamping hasoccurred, the upper latch arm 118 on the release button 39 is engagedwith the second notch 148 on the drive member 138 such that the metaldrive rod 140 is locked in its proximal-most position, as depicted inFIG. 6. When the upper latch arm 118 falls into the recess 122, theupper latch arm 118 disengages with the second notch 148 to permitdistal movement of the metal drive rod 140, as depicted in FIG. 9.

Because the first gear rack 141 on the drive member 138 and the gearrack 154 on the metal drive rod 140 are engaged with the multiplier 136,movement of the firing trigger 28 causes the metal drive rod 140 toreciprocate between a first reciprocating position, shown in FIG. 8, anda second reciprocating position, shown in FIG. 9. Since the diameter ofthe first pinion gear 150 is greater than the diameter of the secondpinion gear 152, the multiplier 136 moves the reciprocating section 134a greater distance than the drive member 138 is moved by the firingtrigger 28. The diameters of the first and second pinion gears 150 and152 may be changed to permit the length of the stroke of the firingtrigger 28 and the force required to move it to be varied. It will beappreciated that the handle portion 20 is illustrative and that otheractuation mechanisms may be employed. For instance, the closing andfiring motions may be generated by automated means.

One embodiment of an end effector 12 of the surgical stapling andsevering instrument 10 is depicted in further detail in FIGS. 18, 19,and 23-26. As described above, the handle portion 20 produces separateand distinct closing and firing motions that actuate the end effector12. The end effector 12 advantageously maintains the clinicalflexibility of this separate and distinct closing and firing (i.e.,stapling and severing). In addition, the end effector 12 introduces theaforementioned ability to affirmatively maintain the closed spacingduring firing after the clinician positions and clamps the tissue. Bothfeatures procedurally and structurally enhance the ability of thesurgical stapling and severing instrument 10 by ensuring adequatespacing for instances where an otherwise inadequate amount of tissue isclamped and to enhance the clamping in instances where an otherwiseexcessive amount of tissue has been clamped.

FIG. 10 depicts a staple cartridge embodiment 300 of the presentinvention installed in the end effector 12 with the firing bar 14 in itsunfired, proximal position. The staple cartridge 300 has a cartridgebody 302 that is divided by an elongated slot 310 that extends from aproximal end 304 of the cartridge 300 towards a tapered outer tip 306. Aplurality of staple-receiving channels 320 a-320 f are formed within thestaple cartridge body 302 and are arranged in six laterally spacedlongitudinal rows 500, 502, 504, 506, 508, 510, with three rows on eachside of the elongated slot 310. Positioned within the staple-receivingchannels 320 a-320 f are the staples 222. See FIGS. 10 and 11.

The cartridge 300 further includes four laterally spaced longitudinalrows of staple drivers 330 a, 330 b, 370 a, and 370 b as shown in FIG.11. The “first” inside staple drivers 330 a are slidably mounted withincorresponding channels 320 b and 320 c such that each driver 330 asupports two staples 222, one in a channel 320 b and one in a channel320 c. Likewise, the “second” inside drivers 330 b are slidably mountedwithin channels 320 d and 320 e such that each driver 330 b supports twostaples 222, one in a channel 320 d and one in a channel 320 e. The“outside” drivers 370 a and 370 b are slidably mounted within thestaple-receiving channels 320 a and 320 f, respectively. Each of theoutside drivers 370 a and 370 b supports a single staple 222. Drivers370 a are referred to herein as “first” outside drivers and drivers 370b are referred to herein as “second” outside drivers.

FIG. 12 illustrates a staple 222 that may be used in connection with thevarious embodiments of the present invention. The staple 222 includes amain portion 223 and two prongs 225. The prongs 225 each have a length“P” and the main portion has a width “W”. The reader will appreciatethat a variety of different types of staples may be employed. Forexample, for a vascular staple, “P” may be approximately 0.102 inches;for a regular staple, “P” may be approximately 0.134 inches; and for athick tissue staple, “P” may be approximately 0.160 inches. For all suchstaples, “W” may be approximately 0.120 inches. Other sizes of staples222 may be employed in the manners discussed below.

The inside staple drivers 330 a located on one side of the elongatedslot 310 are referred to herein as “first” inside staple drivers and theinside staple drivers 330 b located on the other side of the elongatedslot 310 are referred to herein as “second” inside staple drivers. Aswill be discussed in further detail below, in one embodiment, the secondinside staple drivers 330 b are identical to the first inside stapledrivers 330 a, except for their orientation in their respective channelsin the cartridge body 302.

FIGS. 13-15 illustrate one embodiment of a “first” inside double driver330 a for supporting and driving staples 222. As can be seen in thoseFigures, the staple driver 330 a has a primary driver portion 340 and asecondary driver portion 350 that is connected to the first primaryportion 340 by a central base member 360. The primary driver portion 340has a primary driver base 342 that has a groove 343 therein adapted tomate with a corresponding vertically extending tongue (not shown) in thecartridge body 302 for guiding and stabilizing the driver 330 a as itmoves within its respective channel. The primary driver portion 340further has a first forward support column 344 and a first rearwardsupport column 346 protruding upward from the first driver base 342. Thefirst forward support column 344 has a first forward staple-receivinggroove 345 therein and the first rearward support column 346 has a firstrearwardly staple-receiving groove 347 therein. See FIGS. 13-15. Thefirst forward support column 344 and the first rearward support column346 are spaced from each other and collectively form a first staplecradle 348 for supporting the main portion 223 of the staple 222therein.

Similarly, the secondary driver portion 350 has a secondary driver base352 and a secondary forward support column 354 and a secondary rearwardsupport column 356 protruding out from the second driver base 352. Thesecondary forward support column 354 has a secondary forwardstaple-receiving groove 355 therein and the secondary rearward supportcolumn 356 has a secondary rearward staple-receiving groove 357 therein.The secondary forward support column 354 and the secondary rearwardsupport column 356 are spaced from each other and collectively form asecondary staple cradle 358 for supporting the main portion 223 ofanother staple 222 therein.

As can be seen in FIGS. 13 and 15, the central base member 360 has anangled rearwardly facing edge 362 adapted to be engaged by acorresponding sled cam as will be discussed in further detail below. Ascan be seen in FIGS. 13 and 14, in this embodiment, the secondaryforward support column 354 of the secondary driver portion is orientedrelative to the first rearward support column 346 such that the staple222 that is supported in the secondary staple cradle 358 islongitudinally offset from the staple 222 in the first staple cradle348.

The reader will appreciate that the first inside drivers 330 a are eachinstalled in one orientation into a corresponding pair of channels 320 band 320 c located on one side of the elongated slot 310 in the cartridgebody 302. The second inside staple drivers 330 b (located on theopposite side of the elongated slot 310 from the first inside stapledrivers 330 a) comprise inside drivers 330 a rotated 180 degrees so thattheir respective angled surfaces 363 face towards the proximal end 304of the cartridge 300 to enable them to be installed in pairs ofcorresponding channels 320 d and 320 e. Thus, in this embodiment, onlyone inside driver configuration is employed which thereby eliminates theneed for two different inside staple driver configurations for channelson each side of the elongated slot 310.

FIGS. 16 and 17 illustrate one embodiment of a “first” outside stapledriver 370 a. As can be seen in those FIGS., a first outside stapledriver 370 a has a second base 372 that has an angled rearwardly facingportion 374. Protruding upward from the second base 372 is a secondforward support column 375 that has a second forward staple-receivinggroove 376 therein. A second rearward support column 377 also protrudesupward from the second base 372 in a spaced-apart relationship withrespect to the second forward support column 375. The second rearwardsupport column 377 has a second rearward staple-receiving groove 378therein. The support columns 375, 377 collectively form a second staplecradle 379 that is configured to support a staple 222 therein asillustrated in FIGS. 16 and 17. The staple drivers 370 a also have alaterally protruding rib 371 which is received in a corresponding groove(not shown) in the cartridge body 302 for guiding and stabilizing thedriver 370 a as it moves within its respective channel.

The reader will appreciate that a first outside driver 370 a isinstalled in one orientation into a corresponding channel 320 a on oneside of the elongated slot 310. A second outside staple driver 370 b (tobe located on the opposite side of the elongated slot 310 from the firstoutside staple drivers 370 a) comprises an outside driver 370 a rotated180 degrees so that the angled surface 374′ thereon faces toward theproximal end 304 of the cartridge 300 to enable it to be installed in acorresponding channel 320 f in the cartridge body 302. Thus, in thisembodiment, only one outside staple driver configuration is employedwhich avoids the need for two different outside staple driverconfigurations for channels on each side of the elongated slot 310.

FIGS. 19 and 19A illustrate in cross-section one embodiment of a staplecartridge of the present invention mounted within one type of endeffector 12. The end effector 12 in this embodiment employs a “stepped”anvil 18 of the type illustrated in FIGS. 23-25. In other embodiments,however, the bottom surface of the anvil is planar and not stepped.Other As can be seen in FIGS. 19A, and 23-25, the anvil 18 has a centralportion 19 that is offset or not coplanar with the two lateral sideportions 21, 23. Accordingly, in this embodiment, the upper surface 306of the cartridge 300 is provided with a recessed central portion 307 andtwo lateral side portions 309 that are adapted to closely mate with thecorresponding portions 19, 21, 23, respectively, of the anvil 18, whenthe anvil 18 is in the closed position. See FIG. 19A.

As can be seen in FIG. 24, in this embodiment, the under surfaces 200 ofanvil 18 are provided with a series of forming pockets 202 that may bearranged in rows that correspond to the rows of channels in thecartridge 300. That is, row 205 of pockets 202 may correspond to channelrow 500. Row 207 of pockets may correspond to channel row 502. Row 209of pockets 202 may correspond to channel row 504. Row 211 of pockets 202may correspond to channel row 506. Row 213 of pockets 2020 maycorrespond to channel row 508. Row 215 of pockets 202 may correspond tochannel row 510. Each pocket 202 has at least one forming surface 203therein that is adapted to contact the ends of the staple prongs 225being driven therein to thereby cause the prongs 225 to bend inwardlytoward each other. In one embodiment, each pocket 202 has twointersecting arcuate forming surfaces 203 that are oriented as shown inFIG. 14A. Each arcuate forming surface has an apex 203′ that defines amaximum pocket depth “Z”. However other forming pocket configurationscould be employed.

Returning to FIGS. 18 and 19, it can be seen that in one embodiment, thecartridge body 302 is mounted within the cartridge tray 224. Asillustrated in FIG. 19, the cartridge body 302 is formed with two insidelongitudinally extending slots 390 and two outside longitudinallyextending slots 392. Slots 390 and 392 extend from the proximal end 304of the cartridge to its tapered outer tip 306 (shown in FIG. 10). Thisembodiment further includes a wedge sled 400 that slidably supported onthe cartridge tray 224. One wedge sled embodiment 400 includes a pair ofinside sled cams 410, wherein one inside sled cam 410 corresponds to oneof the inside longitudinally extending slots 390 and wherein the otherinside sled cam 410 corresponds to the other inside longitudinallyextending slot 390. See FIG. 19. The wedge sled 400 further includes apair of outside sled cams 420, wherein one outside sled cam 420corresponds to one of the outside longitudinally extending slots 392 andthe other outside sled cam 420 corresponds to the other outsidelongitudinally extending slot 392 as shown in FIG. 19. When assembled,the cartridge tray 224 holds the wedge sled 400 and the drivers 330 a,330 b, 370 a, 370 b inside the cartridge body 302.

As can be seen in FIG. 18, the elongate channel 16 has a proximallyplaced attachment cavity 226 that receives a channel anchoring member228 on the distal end of the frame 34 for attaching the end effector 12to the handle portion 20. The elongate channel 16 also has an anvil camslot 230 that pivotally receives an anvil pivot 232 of the anvil 18. Theclosure sleeve 32 that encompasses the frame 34 includes a distallypresented tab 234 that engages an anvil feature 236 proximate but distalto the anvil pivot 232 on the anvil 18 to thereby effect opening andclosing of the anvil 18. The firing drive member 36 is shown as beingassembled from the firing bar 14 attached to a firing connector 238 bypins 240, which in turn is rotatingly and proximally attached to themetal drive rod 140. The firing bar 14 is guided at a distal end of theframe by a slotted guide 239 inserted therein.

FIGS. 20-23 illustrate one embodiment of the wedge sled 400 of thepresent invention. As can be seen in FIGS. 20 and 23, the wedge sled 400includes a central spacer portion 402 that extends between the insidesled cams 410. A pusher block 404 is formed on the central spacerportion 402 for engagement with the middle pin 46 of the firing bar 14.A side profile of one embodiment of an inside sled cam 410 is depictedin FIG. 21. As can be seen in that FIG., the inside sled cam 410 has abottom surface 412, and a first camming surface 414 that forms an angle“G” with the bottom surface 412 and a second camming surface 415 thatextends to a top surface 416. In one embodiment, for example, the angle“G” may be 35 degrees and the angle “G′” may be 20 degrees. The heightof the inside sled cam 410 (the distance between the bottom surface 412and the top surface 416) is represented as “first” sled cam height “H”.In one embodiment, distance “H’ is approximately 0.173 inches and thelength of the top surface 416 may vary from embodiment to embodiment. Aswill be further evident as the present Detailed Description proceeds,the first sled cam height represents the vertical distance that theinside sled cams 410 will drive the corresponding inside drivers 330 a,330 b toward the anvil 18 during operation.

The wedge sled 400 further comprises lateral spacer portions 406 thatextend between the inside sled cams 410 and the outside sled cams 420 asshown in FIGS. 20 and 23. A side profile of one embodiment of an outsidesled cam 420 is depicted in FIG. 22. In this embodiment, the outsidesled cam 420 has a bottom surface 422 and a first camming surface 424that forms an angle “I” with respect to the bottom surface 422 and asecond camming surface 425 that to a top surface 426. In one embodiment,angle “I” may be approximately 35 degrees and angle “I′” may beapproximately 20 degrees. The height of the outside sled cam 420 (thedistance between the bottom surface 412 and the top surface 416) isrepresented as the “second” sled cam height “J”. In one embodiment,distance “J’ is approximately 0.163 inches. The second sled cam heightrepresents the vertical distance that the outside sled cams 420 willdrive the corresponding outside drivers 370 a, 370 b toward the anvil 18during operation. The reader will understand that the above-reciteddimensions are illustrative of one embodiment and may vary for otherembodiments.

With particular reference to FIG. 23, a portion of the staple cartridge300 is removed to expose portions of the elongate channel 16, such asrecesses 212, 214 and to expose some components of the staple cartridge300 in their unfired position. In particular, the cartridge body 302(shown in FIG. 18) has been removed. The wedge sled 400 is shown at itsproximal, unfired position with a pusher block 404 contacting the middlepin 46 (not shown in FIG. 23) of the firing bar 14. The wedge sled 400is in longitudinal sliding contact upon the cartridge tray 224 andincludes wedges sled cams 410, 420 that force upward the double drivers330 a, 330 b and the single drivers 370 b, 370 b as the wedge sled 400moves distally. Staples 222 (not shown in FIG. 23) resting upon thedrivers 330 a, 330 b, 370 a, 370 b are thus also forced upward intocontact with the anvil forming pockets 202 in anvil 18 to form closedstaples. Also depicted is the channel slot 45 in the elongate channel 16that is aligned with the elongated slot 310 in the staple cartridge 300.

FIG. 24 depicts the end effector 12, which is in an open position by aretracted closure sleeve 32, with a staple cartridge 300 installed inthe elongate channel 16. The firing bar 14 is at its proximal position,with the upper pin 38 aligned in a non-interfering fashion with theanvil pocket 40. The anvil pocket 40 is shown as communicating with thelongitudinal anvil slot 42 in the anvil 18. The distally presentedcutting edge 48 of the firing bar 14 is aligned with and proximally fromremoved from the vertical slot 49 in the staple cartridge 300, therebyallowing removal of a spent cartridge and insertion of an unfiredcartridge, which may be “snapfit” into the elongate channel 16.Specifically, in this embodiment, extension features 316, 318 of thestaple cartridge 300 engage recesses 212, 214, respectively (shown inFIG. 23) of the elongate channel 16.

FIG. 25 depicts the end effector 12 of FIG. 23 with all of the staplecartridge 300 removed to show the middle pin 46 of the firing bar 14 aswell as portion of the elongate channel 16 removed adjacent to thechannel slot 45 to expose the firing bar cap 44. In addition, portionsof the shaft 23 are removed to expose a proximal portion of the firingbar 14. Projecting downward from the anvil 18 near the pivot is a pairof opposing tissue stops 244 which serve to prevent tissue from beingpositioned too far up into the end effector 12 during clamping.

FIG. 26 depicts the end effector 12 in a closed position with the firingbar 14 in an unfired position. The upper pin 38 is in the anvil pocket40 and is vertically aligned with the anvil slot 42 for distallongitudinal movement of the firing bar 14 during firing. The middle pin46 is positioned to push the wedge sled 400 distally so that the sledcams 410, 420 contact and lift double drivers 330 a, 330 b and thesingle drivers 370 a, 370 b, respectively, to drive them upwardly towardthe anvil 18.

As can be appreciated from reference to FIGS. 14A, 15A and 19A, in oneembodiment of the present invention, the distance between the bottom ofthe first staple-receiving grooves 345, 347 forming the first staplecradle 349 and the apex 203′ of forming surfaces 203 of thecorresponding forming pocket 202 of anvil 18, when the anvil 18 is inthe closed position and when the inside driver 330 a, 330 b is supportedon the cartridge tray 224, is referred to herein as the first stapleforming distance “A”. The distance between the bottom of the secondarystaple-receiving grooves 345, 347 forming the secondary staple cradle349 and the apex 203′ of the forming surface 203 of the correspondingforming pocket 202 in the anvil 18 when the anvil 18 is in the closedposition and the inside driver 330 a, 330 b is supported on thecartridge tray 224 is referred to herein as the secondary staple formingdistance “B”. In one embodiment, the first staple forming distance “A”and the secondary staple forming distance “B” are substantially equal toeach other. In other embodiments, those distances “A” and “B” may differfrom each other.

As illustrated in FIGS. 16A and 19A the distance between the bottom ofthe second staple-receiving grooves 376, 378 that form the second staplecradle 379 and the apex 203′ of the forming surface 203 of acorresponding forming pocket 202 in anvil 18 when the anvil 18 is in theclosed position and the outside drivers 370 a, 370 b are supported onthe cartridge channel 224, is referred to herein as a “second” stapleforming distance “C”.

FIGS. 27 and 28 illustrate the forming of staples supported on some ofthe first outside drivers 370 a. In FIG. 27, one of the outside sledcams 420 of the wedge sled 400 is initially contacting one of theoutside drivers 370 a. As the wedge sled 400 continues in the drivingdirection represented by arrow “K” in FIG. 28, the outside sled cam 420causes the outside drivers 370 a drive the staples 222 supported therebyinto the staple forming pockets 202 in the anvil 18. Likewise, as thewedge sled 400 is driven in the driving direction “K”, the inside sledcams 410 contact the inside drivers 330 a, 330 b and causes them todrive the staples 222 supported thereby into the corresponding stapleforming pockets 202 in the anvil 18.

As indicated above, in some applications involving an area of variedtissue composition, it can be desirable to form rows of staples whereinthe formed (final) heights of the staples in a row that is the farthestdistance away from the cut line are greater than the formed (final)heights of those staples in the row that is closest to the cut line. Inother applications, it may be desirable for the formed heights of thestaples in a single row to increase (or decrease) from staple to staple.Another clinical benefit would be to have the formed heights of thestaples in the outermost rows larger than formed heights of the staplesin the inside rows. The various embodiments of the subject invention canprovide these results while employing identical staples in all of therows.

As the present Detailed Description proceeds, those staples 222 in theoutermost rows 520, 530 of staples (those staples formed using theoutside staple drivers 370 a, 370 b) will be referred to hereinafter asstaples 222′ and those staples in the innermost rows 522, 524, 526, 528of staples (those staples formed using the inside staple drivers 330 a,330 b) will be referred to hereinafter as staples 222″. It will beunderstood, however, that staples 222′ and 222″ are identical to eachother prior to being formed by the various embodiments of the presentinvention. That is, staples 222′ and 222″ each have identical pronglengths “P” and widths “W”.

Returning to FIGS. 14A-16A and 21 and 22, the above desired effects maybe attained by altering the staple forming distances “A”, “B”, and “C”relative to each other and/or the sled cam heights “H” and “J”. In oneembodiment of the subject invention, for example, the height “H” of eachof the inside sled cams 410 is substantially equal to the sled height“J” of each of the outside sled cams 420. See FIGS. 21 and 22. In thisembodiment, the staple forming distances “A” and “B” are substantiallyequal to each other, but distances “A” and “B” are less than the stapleforming distance “C”. The distance “D” between the bottoms of the firststaple-receiving grooves 345, 347 and the bottom surface 342′ of theprimary driver base 342 is substantially equal to the distance “E”between the bottoms of the secondary staple-receiving grooves 356, 357and the bottom surface 352′ of the secondary driver base portion 352.See FIG. 15. Also in this embodiment, the distance “F” between thebottoms of the second staple-receiving grooves 376 and 378 and thebottom surface 373 of the third base 372 of the outside drivers 370 a,370 b (FIG. 16) is less than distances “D” and “E” (FIG. 15). Becausethe forming distance “C” is greater than the forming distances “A” and“B”, the staples 222 supported and formed by the outside drivers 370 a,370 b are not compressed as much as the staples supported and formed bythe inside drivers 330 a, 330 b. It will be understood that similarresults may be attained on the opposite side of the elongated slot 310and the cut line 600 formed in the tissue by using the same arrangementsand sizes of inside drivers 330 b and outside drivers 370 b. In analternative embodiment, the same effect may be achieved by altering thedepths of the forming pockets 202 corresponding to the drivers 330 a and370 b such that forming distance “C” is greater than the formingdistances ‘A″ and “B”. That is, the depth (distance “Z’” in FIG. 16A) ofthe those forming pockets 202 corresponding to the outside drivers 370a. 370 b may be greater than the depth (distance “Z” in FIG. 14A) of theforming pockets 202 that correspond to the inside drivers 330 a, 330 b.

FIG. 29 illustrates the rows of staples formed on each side of a cutline 600 utilizing this embodiment of the present invention wherein theforming distances “A” and “B” are equal to each other and the formingdistance “C” is greater than the forming distances “A” and “B”. Forexample, if forming distance “C” is 0.020″ greater than formingdistances “A” and “B”, the formed height of the outside staples 222′(represented as dimension “L” in FIG. 30) in rows 520 and 530 would be0.020 inches is greater than the formed height of the inside staples222″ (represented as dimension “M” in FIG. 31) in rows 522. 524, 526,528.

The same result may be achieved by utilizing another embodiment of thepresent invention wherein the forming distances “A”, “B” and “C” areessentially equal. In this embodiment, however, the height of each ofthe inside sled cams 410 (distance “H” in FIG. 21) is greater than theheight of each of the outside sled cams 420 (distance “J” in FIG. 22).Thus, because the height “H” of the inside sled cams 410 is greater thanthe height “J′” of the outside sled cams 420, the inside sled cams 410will drive the corresponding inside drivers 330 a, 330 b further towardsthe anvil than the outside sled cams 420 will drive the correspondingoutside drivers 370 a, 370 b. Such driving action will cause the staplessupported by the inside drivers 330 a, 330 b to be compressed to agreater extent than those staples supported by the outside drivers 370a, 370 b. For example, if distance “H” is 0.020 inches greater thandistance “J”, the formed height of staples 222′ in lines 520, 530 wouldbe 0.020″ greater than the formed height of staples 222″ in lines 522,524, 526, 528.

When employing yet another embodiment of the present invention, theoutside rows 520, 530 of staples 222′ and the inside rows 522, 528 ofstaples 222″ may be formed with heights that are greater than the formedheights of the staples 222″ in the inside rows 524, 526. See FIG. 32.This result is achieved by making the forming distances “C” greater thanthe forming distance “A” and making forming distance “A” greater thansecondary forming distance “B”.

Another embodiment of the present invention can be used to installstaples where it is desirable for the formed heights of staples in asingle row to vary. One such arrangement is depicted in FIG. 33. As canbe seen in FIG. 33, the formed heights of the staples 222′ in theoutside rows 520, 530 increase when moving from the proximal ends 521,531 of each row 520, 530, respectively to the distal ends 523, 533 ofeach row 520, 530, respectively. This effect may be accomplished bydecreasing the forming distance “C” for each succeeding driver 370 a,370 b. That is, the driver 370 a closest the proximal end of thecartridge 300 would be sized to establish a forming distance “C” that isgreater than the forming distance “C” achieved by the adjacent driver370 a and so on to achieve a condition wherein each succeeding staple222′ (moving in the direction from the proximal end to the distal end ofthe cartridge 300) would have larger formed heights. This result couldalso be attained in the staples 222″ in rows 522, 524, 526, 528 bysimilarly altering the forming distances “A” and/or “B” attained by eachdriver 330 a, 330 b. Likewise, formed heights of the staples 222′ in theoutside rows 520, 530 could be made to decrease when moving from theproximal ends 521, 531 of each row 520, 530, respectively, to the distalends 523, 533 of each row 520, 530, respectively. This result may beattained by increasing the forming distance of each succeeding driver370 a, 370 b. That is, the driver 370 a closest the proximal end of thecartridge 300 would have a forming distance “C” that is less than theforming distance “C” of the adjacent driver 370 a and so on to achieve acondition wherein each succeeding staple 222′ (moving in the directionfrom the proximal end to the distal end of the cartridge) would havesmaller formed heights. See FIG. 34.

In use, the surgical stapling and severing instrument 10 is used asdepicted in FIGS. 1-2 and 35-41. In FIGS. 1-2, the instrument 10 is inits start position, having had an unfired, fully loaded staple cartridge300 snap-fitted into the distal end of the elongate channel 16. Bothtriggers 26, 28 are forward and the end effector 12 is open, such aswould be typical after inserting the end effector 12 through a trocar orother opening into a body cavity. The instrument 10 is then manipulatedby the clinician such that tissue 248 to be stapled and severed ispositioned between the staple cartridge 300 and the anvil 18, asdepicted in FIG. 35.

With reference to FIGS. 36 and 37, the clinician then moves the closuretrigger 26 proximally until positioned directly adjacent to the pistolgrip 24, locking the handle portion 20 into the closed and clampedposition. The retracted firing bar 14 in the end effector 12 does notimpede the selective opening and closing of the end effector 12, butrather resides within the anvil pocket 40. With the anvil 18 closed andclamped, the E-beam firing bar 14 is aligned for firing through the endeffector 12. In particular, the upper pin 38 is aligned with the anvilslot 42 and the elongate channel 16 is affirmatively engaged about thechannel slot 45 by the middle pin 46 and the firing bar cap 44.

With reference to FIGS. 38 and 39, after tissue clamping has occurred,the clinician moves the firing trigger 28 proximally causing the firingbar 14 to move distally into the end effector 12. In particular, themiddle pin 46 enters the staple cartridge 300 through the firing driveslot 47 to effect the firing of the staples 222 (not shown in FIGS. 38and 39) via wedge sled 400 toward the anvil 18. The lowermost pin, orfiring bar cap 44, cooperates with the middle pin 46 to slidinglyposition cutting edge 48 of the firing bar 14 to sever tissue. The twopins 44, 46 also position the upper pin 38 of the firing bar 14 withinlongitudinal anvil slot 42 of the anvil 18, affirmatively maintainingthe spacing between the anvil 18 and the elongate channel 16 throughoutits distal firing movement.

With reference to FIGS. 40 and 41, the clinician continues moving thefiring trigger 28 until brought proximal to the closure trigger 26 andpistol grip 24. Thereby, all of the ends of the staples 222 are bentover as a result of their engagement with the anvil 18. The firing barcap 44 is arrested against a firing bar stop 250 projecting toward thedistal end of the channel slot 45. The cutting edge 48 has traversedcompletely through the tissue. The process is complete by releasing thefiring trigger 28 and by then depressing the release button 30 whilesimultaneously squeezing the closure trigger 26 to open the end effector12.

While the present invention has been illustrated by description ofseveral embodiments and while the illustrative embodiments have beendescribed in considerable detail, it is not the intention of theapplicant to restrict or in any way limit the scope of the appendedclaims to such detail. Additional advantages and modifications mayreadily appear to those skilled in the art. The various embodiments ofthe present invention represent vast improvements over prior staplemethods that require the use of different sizes of staples in a singlecartridge to achieve staples that have differing formed (final) heights.

Accordingly, the present invention has been discussed in terms ofendoscopic procedures and apparatus. However, use herein of terms suchas “endoscopic” should not be construed to limit the present inventionto a surgical stapling and severing instrument for use only inconjunction with an endoscopic tube (i.e., trocar). On the contrary, itis believed that the present invention may find use in any procedurewhere access is limited to a small incision, including but not limitedto laparoscopic procedures, as well as open procedures. Moreover, theunique and novel aspects of the various staple cartridge embodiments ofthe present invention may find utility when used in connection withother forms of stapling apparatuses without departing from the spiritand scope of the present invention.

1. A staple cartridge for use with a stapling device that has anactuator that is selectively actuatable in an axial direction and ananvil portion that is selectively movable between open and closedpositions, said staple cartridge comprising: a cartridge bodysupportable within the stapling device for selective confrontingrelationship with the anvil portion thereof when in a closed position,said cartridge body configured to axially receive the actuator therein;at least one first staple driver movably supported within said cartridgebody for contact by the actuator such that, as the actuator is axiallyadvanced through said cartridge body, said first staple drivers aredriven in a direction toward the anvil when the anvil is in the closedposition, each said first staple driver defining a first staple supportcradle therein for supporting a staple thereon, said first staplesupport cradle located a first staple forming distance from acorresponding portion of the closed anvil; and at least one secondstaple driver movably supported within said cartridge body for contactby the actuator such that as the actuator is axially advanced throughsaid cartridge body, said second staple drivers are driven in saiddirection toward the closed anvil, each said second staple driverdefining a second staple support cradle therein for supporting anotherstaple thereon, said second staple support cradle located a secondstaple forming distance from another portion of the closed anvil whereinsaid second staple forming distance differs from said first stapleforming distance.
 2. The staple cartridge of claim 1 wherein each saidfirst staple driver supports at least two of said staples thereon. 3.The staple cartridge of claim 2 wherein said first staple support cradleis in a primary driver portion of said first staple driver and whereineach said first staple driver further comprises a secondary driverportion attached to said primary driver portion and defining a secondarystaple support cradle located a secondary staple forming distance fromanother corresponding portion of the anvil when the anvil is in a closedposition, said secondary support cradle supporting another one of saidstaples thereon.
 4. The staple cartridge of claim 3 wherein saidsecondary staple forming distance is substantially equal to said firststaple forming distance.
 5. The staple cartridge of claim 3 wherein saidsecondary staple forming distance differs from said first staple formingdistance and said second staple forming distance.
 6. The staplecartridge of claim 1 wherein said at least one first staple drivercomprises a plurality of first staple drivers axially aligned in a firstrow of first staple drivers and wherein said at least one said secondstaple driver comprises a plurality of second staple drivers aligned ina second row of said second staple drivers.
 7. The staple cartridge ofclaim 6 wherein said first staple forming distance of one said firststaple drivers in said first row of said first staple drivers differsfrom said first staple forming distance of another one of said firststaple drivers in said first row of first staple drivers.
 8. The staplecartridge of claim 7 wherein said second staple forming distance of oneof said second staple drivers in said second row of said second stapledrivers differs from said second staple forming distance of another oneof said second staple drivers in said second row of said second stapledrivers.
 9. A staple cartridge for use with a surgical instrument havingan end effector that has an anvil portion pivotally attached thereto fortravel between open and closed positions and further including a firingbar that is selectively axially reciprocatable therein, said staplecartridge comprising: a cartridge body sized to be supported within theend effector, said cartridge body having a longitudinally extending slottherein for reciprocatingly receiving the firing bar therein; a firstplurality of inside staple drivers axially aligned in a first row ofinside staple drivers in a portion of said cartridge body adjacent afirst side of said longitudinally extending slot and a second pluralityof inside staple drivers axially aligned in a second row of insidestaple drivers in another portion of said cartridge body adjacent asecond side of said longitudinally extending slot, said inside stapledrivers movably supported within said cartridge body for selectivemovement toward the anvil when the anvil is in a closed position, eachsaid inside staple driver defining a first staple support cradle forsupporting a staple thereon, each said first staple support cradlelocated a first staple forming distance from a corresponding portion ofthe anvil when the anvil is in a closed position; a first plurality ofoutside staple drivers axially aligned in a first row of outside stapledrivers adjacent to said first row of said inside staple drivers and asecond plurality of outside staple drivers axially aligned in a secondrow of outside staple drivers and adjacent to said second row of insidestaple drivers, each of said outside staple drivers movably supportedwithin said cartridge body for selective driving movement toward theanvil when the anvil is in the closed position, each of said outsidestaple drivers defining a second staple support cradle for supportinganother one of said staples thereon, each said second staple supportcradle located a second staple forming distance from anothercorresponding portion of the anvil when the anvil is in the closedposition, said second staple forming distance differing from said firststaple forming distance; and a wedge sled supported within saidcartridge body for driving contact by the firing bar and actuatingcontact with said first and second pluralities of said inside stapledrivers and said first and second pluralities of said outside stapledrivers such that, as said firing bar moves within said elongated slotin said cartridge body in a first axial direction, said wedge sleddrives each of said inside and outside drivers towards the anvil tobring the staples supported thereon into forming contact with the anvilwhen the anvil is in the closed position.
 10. The staple cartridge ofclaim 9 wherein each of said inside staple drivers support two of saidstaples thereon.
 11. The staple cartridge of claim 10 wherein said twostaples supported on at least one of said inside staple drivers arelongitudinally offset from each other.
 12. The staple cartridge of claim10 wherein said first staple support cradle is in a primary driverportion of said inside driver and wherein each said inside driverfurther comprises a secondary driver portion attached to said primarydriver portion, said secondary driver portion defining a secondarystaple support cradle therein that is located a secondary staple formingdistance from another corresponding portion of the anvil when the anvilis in the closed position, each said secondary staple support cradlesupporting one of said staples thereon.
 13. The staple cartridge ofclaim 12 wherein said secondary staple forming distance is substantiallyequal to said first staple forming distance.
 14. The staple cartridge ofclaim 12 wherein said secondary staple forming distance differs fromsaid first staple forming distance and said second staple formingdistance.
 15. The staple cartridge of claim 9 wherein said second stapleforming distance of at least one of said outside staple drivers in saidfirst row of said first outside staple drivers differs from said secondstaple forming distance of at least one other said outside staple driverin said first row of said outside staple drivers.
 16. The staplecartridge of claim 15 wherein said second staple forming distance of atleast one of said outside staple drivers in said second row of saidoutside staple drivers differs from said second staple forming distanceof at least one other said outside staple driver in said second row ofsaid outside staple drivers.
 17. The staple cartridge of claim 9 whereinsaid first staple forming distance of at least one of said first stapledrivers in said first row of said inside staple drivers differs fromsaid first staple forming distance of at least one other said insidestaple driver in said first row of said inside staple drivers.
 18. Thestaple cartridge of claim 15 wherein said first staple forming distanceof at least one of said inside staple drivers in said second row of saidinside staple drivers differs from said first staple forming distance ofat least one other said inside staple driver in said second row of saidinside staple drivers.
 19. A staple cartridge for use with a surgicalinstrument having an end effector that has an anvil portion pivotallyattached thereto for travel between open and closed positions andfurther including a firing bar that is selectively axiallyreciprocatable therein, said staple cartridge comprising: a cartridgebody sized to be supported within the end effector, said cartridge bodyhaving a longitudinally extending slot therein for reciprocatinglyreceiving the firing bar therein; a plurality of first inside stapledrivers axially aligned in a first row of first inside staple drivers ona first side of said longitudinally extending slot, each of said firstinside staple drivers movably supported within said cartridge body forselective movement toward the anvil when the anvil is in a closedposition and supporting at least one staple thereon; a plurality offirst outside staple drivers axially aligned in a first row of firstoutside staple drivers on said first side of said longitudinallyextending slot and adjacent to said first row of said first insidestaple drivers, each of said first outside staple drivers movablysupported within said cartridge body for selective driving movementtoward the anvil when the anvil is in the closed position and supportinganother one of said staples thereon; and a wedge sled supported withinsaid cartridge body for contact with said firing bar, said wedge sledcomprising: a first inside sled cam having a first sled cam height, saidfirst inside sled cam oriented for sequential sliding actuating contactwith said first inside staple drivers in said first row of said firstinside staple drivers when said firing bar is axially advanced throughsaid elongated slot in a first axial direction such that said firstinside staple drivers are driven towards the anvil a first distanceequal to said first sled cam height; and a first outside sled cam havinga second sled cam height that differs from said first sled cam height,said first outside sled cam oriented for sequential sliding actuatingcontact with said first outside staple drivers in said first row of saidfirst outside staple drivers when said firing bar is axially advancedthrough said elongated slot in the first axial direction such that saidfirst outside staple drivers are driven towards the anvil a seconddistance equal to said second sled cam height.
 20. The staple cartridgeof claim 19 further comprising: a plurality of second inside stapledrivers axially aligned in a second row of second inside staple driverson a second side of said longitudinally extending slot, each of saidsecond inside staple drivers movably supported with said cartridge bodyfor selective driving movement towards the anvil when the anvil is inthe closed position and supporting another one of said staples thereon;a plurality of second outside staple drivers axially aligned in a secondrow of second outside staple drivers on said second side of saidlongitudinally extending slot and adjacent to said second row of saidsecond inside staple drivers, each of said second outside staple driversmovably supported within said cartridge body for driving movementtowards the anvil when the anvil is in the closed position andsupporting another one of said staples thereon and wherein said wedgesled further comprises: a second inside sled cam having a primary sledcam height, said second inside sled cam oriented for sequential slidingactuating contact with said second inside staple drivers in said secondrow of said second inside staple drivers when said firing bar is axiallyadvanced through said elongated slot in the first axial direction suchthat said second inside staple drivers are driven towards the anvil aprimary distance equal to said primary sled cam height; and a secondoutside sled cam having a secondary sled cam height, said second outsidesled cam oriented for sequential sliding actuating contact with saidsecond outside staple drivers in said second row of said second outsidestaple drivers when said firing bar is axially advanced through saidelongated slot in the first axial direction such that said secondoutside staple drivers are driven towards the anvil a secondary distanceequal to said secondary sled cam height.
 21. The staple cartridge ofclaim 22 wherein said primary sled cam height is substantially equal tosaid first sled cam height and wherein said secondary sled cam height issubstantially equal to said second sled cam height.
 22. The staplecartridge of claim 22 wherein said primary sled cam height is not equalto said first, second, or secondary sled cam heights.